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The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections

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ClinicalTrials.gov Identifier: NCT03308136
Recruitment Status : Completed
First Posted : October 12, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. But needle handling during the procedure may cause pain and discomfort to the patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In addition, it can reduce the injection site pain that may occur after the procedure.

Condition or disease Intervention/treatment Phase
Lumbar Radiculopathy Due to Spinal Nerve Compression Procedure: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer. Procedure: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway. Drug: 1% Lidocaine Not Applicable

Detailed Description:
  1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
  2. This study is single-blind because it is not possible to blind the practitioner performing the injection.
  3. Subjects were randomly assigned to the subcutaneous anesthesia group (group A) and the muscle anesthesia group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
  4. After the procedure, a resident who does not know of this study records the patient's pain and discomfort. and on follow-up visits, post injection site pain is checked.
  5. Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subcutaneous anesthesia group (group A) muscle anesthesia group (group B)
Masking: Double (Participant, Investigator)
Masking Description:
  1. The subjects were randomly assigned to subcutaneous anesthesia group (group A) and muscle anesthesia group (group B), and the assigned results are unknown.
  2. The Outcomes Assessor is not related to the study, and does not know its contents.
Primary Purpose: Supportive Care
Official Title: The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Arm Intervention/treatment
Experimental: subcutaneous anesthesia group (group A) Procedure: 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.

Drug: 1% Lidocaine
1% Lidocaine

Active Comparator: muscle anesthesia group (group B) Procedure: 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.
2) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.

Drug: 1% Lidocaine
1% Lidocaine




Primary Outcome Measures :
  1. Procedural Pain score (NRS) [ Time Frame: Immediately after the procedure ]
    Numeric Rating Scale(NRS) score : from 0 (No pain) to 10 (worst pain imaginable)


Secondary Outcome Measures :
  1. At the next outpatient visit, whether the injection site pain(Yes) or not(No) [ Time Frame: 2 weeks ]
    At the next outpatient visit, subjects asked about injection site pain (Yes / No) after the last injection.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.

Exclusion Criteria:

  1. Blood clotting disorder
  2. Infection around the site
  3. Contrast agent allergy
  4. Uncontrolled cardiovascular, cerebrovascular, kidney disease
  5. Past history of spinal surgery (ex, spinal fusion)
  6. If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
  7. Patients taking narcotic analgesics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308136


Locations
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Korea, Republic of
Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03308136     History of Changes
Other Study ID Numbers: 4-2017-0683
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
epidural steroid injection
procedural pain
local Anesthetic Injection
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Radiculopathy
Pain, Procedural
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action